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A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE)

NCT07266090 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-20

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the safety, how the body processes the drug, and its effects of a drug called cenerimod in adult Chinese participants (aged 18-75) with moderate to severe Systemic Lupus Erythematosus (SLE) who are already receiving standard background therapy.

The main questions it aims to answer are:

* What is the safety and tolerability of a daily 4 mg dose of cenerimod in Chinese participants with SLE?
* How is cenerimod processed by the body (pharmacokinetics) in this population?
* What is the effect of cenerimod on the level of lymphocytes in the blood (pharmacodynamics)? This is a single-arm study without a comparison group.

Participants will:

* Take one 4 mg cenerimod tablet by mouth once daily for up to 12 months.
* Continue their stable, pre-existing background SLE medications throughout the study.
* Attend regular clinic visits over a period of up to 22 months for tests and check-ups, including blood draws, heart monitoring (12-lead electrocardiogram), vital signs(blood pressure),and physical examinations.
* Undergo a final safety follow-up 6 months after their last dose of the study drug.

Conditions

  • SLE - Systemic Lupus Erythematosus

Interventions

DRUG

cenerimod 4 mg

cenerimod 4 mg once daily for 12 months

Sponsors & Collaborators

  • Viatris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2027-10-08
Completion
2027-10-08

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266090 on ClinicalTrials.gov